drugset / Trial / NCT03668041

National Adaptive Trial for PTSD Related Insomnia

NCT03668041

Phase 3 Completed 673 enrolled VA Office of Research and Development
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Many Veterans with posttraumatic stress disorder (PTSD) have trouble sleeping or have frequent nightmares. So far, no medication has been approved for treatment of insomnia in PTSD. The purpose of this research study is to find out if taking medications called trazodone or eszopiclone can help decrease symptoms of insomnia in patients with PTSD. PTSD is a form of intense anxiety which sometimes results from severe trauma. Symptoms may include nightmares, flashbacks, troublesome memories, difficulty sleeping, poor concentration, irritability, anger, and emotional withdrawal. Insomnia is a disorder that can make it hard to fall sleep, stay asleep or cause a person to wake up too early and not be able to fall back to sleep.

Timeline

Start
2021-02-25
Primary completion
2026-03-30
Completion
2026-03-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Eszopiclone Small molecule
Comparator Trazodone Small molecule

Indications